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Sick Kids apologizes for drug-test failings of its Motherisk lab

Hospital says it “deeply” regrets harm to families caused by “unacceptable” practices by lab whose tests were relied on in court.

"We deeply regret that the practices in the Motherisk drug testing laboratory didn’t meet the high standard of excellence that we have here at Sick Kids, and we extend our sincere apologies to children, families and organizations who feel that they may have been impacted in some negative way,” Dr. Michael Apkon, CEO at the Hospital for Sick Children, told the Star. (Hospital for Sick Children)

The Hospital for Sick Children is apologizing for “unacceptable” practices in its Motherisk drug testing laboratory, its chief executive officer told the Star in an exclusive interview on Thursday.

“We deeply regret that the practices in the Motherisk drug testing laboratory didn’t meet the high standard of excellence that we have here at Sick Kids, and we extend our sincere apologies to children, families and organizations who feel that they may have been impacted in some negative way,” said Dr. Michael Apkon, speaking in his office at the hospital.

“We remain resolved in our efforts to ensure that we have the highest standards of quality and safety in all of our programs so that unacceptable events like this never happen again.”

Sick Kids permanently halted drug and alcohol hair testing at Motherisk last spring in the midst of an internal review, which showed a laboratory operating at times without appropriate oversight or rigorous quality assurance processes, yet relied upon in many child protection and criminal cases across the country.

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Apkon said the hospital has no plans to resume drug and alcohol hair tests.

Sick Kids released a summary of findings from its review on Thursday. The results led the hospital to implement policy changes in areas including conflict of interest, testimony by its doctors and researchers in court, and the Motherisk call centre, which handles inquiries from numerous pregnant and lactating women every year.

A provincial review of Motherisk conducted by retired Court of Appeal Justice Susan Lang is expected by the end of the year. Both probes follow a Star investigation into Motherisk’s testing practices.

“My concern overall is what is going to be done on a go-forward basis,” said Katharina Janczaruk, acting chair of Ontario’s Family Lawyers Association, after reviewing Sick Kids’ summary of findings on Thursday.

“I’m not sure an apology gets to that. It is a first step, and is impressive that Sick Kids is able to do that, but I think we need more from them. They indicate instances where they’re reviewing or developing guidelines. Of course we’d like to know what that review is, what those guidelines are. We’d like a lot more information.”

The Star’s investigation showed that prior to 2010, Motherisk was testing hair using a methodology described by experts as falling short of the “gold-standard test.” And while Motherisk did switch to the gold standard after 2010 for most drugs, the internal review found it was still using the less definitive test for some drugs, including cannabinoids, until the lab was closed in April.

The hospital has never provided the number of cases that relied upon Motherisk testing prior to 2010. Apkon said it would be impossible to give an accurate number without “collaborating” with other partners in the judicial system.

The Sick Kids’ investigation also uncovered that for several years, Motherisk had been misleading the hospital about its testing process. The lab was a participant in the Society of Hair Testing’s “proficiency testing” program, in which hair samples with known quantities of drugs were sent by the SoHT to organizations for testing so that they could compare their results with other participating groups to ensure their processes were reliable.

Unbeknownst to Sick Kids, “results from another laboratory used to confirm results from (Motherisk) were submitted to the SoHT as (Motherisk)’s results,” according to the summary of findings. The issue was apparently resolved in 2011, but only uncovered by hospital brass during the review earlier this year.

“It’s clearly an unacceptable practice; it’s one we don’t condone in any way,” Apkon told the Star. “When we discovered this practice, even though it had gone on and had stopped, we suspended and then permanently closed the lab for all purposes except for research. We’ve prohibited any further use of data collected by the Motherisk drug testing lab, except for research, and we’ve also prohibited the release of data to external parties unless it’s required by law.”

Among the changes stemming from the review is the implementation of a program “to ensure that our staff testifying in court understand their professional responsibilities and their role in the judicial system,” Apkon said. He told the Star that while Motherisk never “held themselves out” as a forensic lab — Motherisk was actually accredited as a clinical lab — the lab’s staff “may not have routinely identified the limitations in their approach or processes in a way that would allow the judicial system to appropriately gauge the credibility of the results.”

A subsequent Star investigation also exposed the lack of disclosure by Motherisk of the funding it received from drug company Duchesnay, even as it routinely advised women on taking Duchesnay’s drug diclectin for morning sickness. This included a booklet on Motherisk’s website co-authored by the lab’s former director, Gideon Koren, called “How to Survive Morning Sickness Successfully,” which promoted the use of the drug.

The hospital has since removed the booklet from its website. Koren, who has never spoken publicly on the controversy surrounding Motherisk, retired in June, Apkon said.

It was also discovered during the review that in two of Koren’s studies, staff had accessed Motherisk call centre records in at least 70 cases to contact people for their consent to use their data, without seeking the approval of the Sick Kids Research Ethics Board. Apkon described that as a privacy breach, and said it has been reported to Ontario’s Information and Privacy Commissioner.

As part of changes to avoid the perception of bias, the hospital has added conflict of interest statements to its Motherisk call centre protocols — such as reminding women of Duchesnay funding when talking about diclectin — as well as on its website. A centralized conflict management committee will be created for the hospital, which is also refreshing its conflict of interest policy on matters around disclosure.

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